G/SPS/N/EU/495  
 
17 June 2021  
(21-4973) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Preparation of a kind used in animal nutrition (HS Code: 2309)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Implementing Regulation (EU) 2021/968 
concerning the renewal of the authorisation of zinc chelate of hydroxy analogue of 
methionine as a feed additive for all animal species, and repealing Regulation (EU) 
No 335/2010 (Text with EEA relevance) . Language(s):  English, French and Spanish . 
Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4208_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4208_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4208_00_s.pdf  
6. Description of content:  Regulation (EC) No 1831/2003 provides for the authorisation of 
additives for use in animal nutrition and for the grounds and procedures for granting and 
renewing such authorisation.  Zinc chelate of hydroxy analogue of methionine was 
authorised for 10 years as a feed additive for all animal species by Commission Regulat ion 
(EU) No 335/2010. In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an 
application was submitted for the renewal of the authorisation of zinc chelate of hydroxy 
analogue of methionine as feed additive for all animal species in the addit ive category 
'nutritional additives'. The application was accompanied by the particulars and documents 
required under Article 14(2) of Regulation (EC) No 1831/2003. It results from the opinion 
of the European Food Safety Authority ('the Authority') of 18 N ovember 2020 that, under 
the proposed conditions of use, zinc chelate of hydroxy analogue of methionine does not 
have an adverse effect on animal health, consumer safety or the environment. The 
Authority also concluded for the additive a risk for the user by inhalation and that it is a 
skin sensitizer. Therefore, the Commission considers that appropriate protective measures 
should be taken to prevent adverse effects on human health, in particular as regards the 
users of the additive. The proof of the effica cy of the additive, on which the initial 
authorisation was based, withstands in a renewal procedure. The Authority also verified 
the report on the method of analysis of the feed additive in feed submitted by the 
Reference Laboratory set up by Regulation (E C) No 1831/2003.  The assessment of zinc 
chelate of hydroxy analogue of methionine shows that the conditions for authorisation, as 
provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the 
authorisation of this additive shou ld be renewed.  G/SPS/N/EU/495  
 
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  7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Code of practice on Good Animal Feeding 
CAC/RCP  54-2004 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 16 June 2021  
Proposed date of publication (dd/mm/yy) : 17 June 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation shall enter into force on the twentieth day following that of 
its publication in the O fficial Journal of the European Union.  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu